FDA Falls Short in Communicating Drug Recalls

JUNE 11, 2012

Daniel Weiss, Senior Editor

The FDA fails to alert health care providers of a significant portion of serious drug recalls and others are lost in a sea of less important alerts, a study finds.
Health care providers receive no communication from the FDA regarding approximately 1 in 5 drug recalls launched due to serious health concerns, and many other such recalls are poorly communicated, according to the results of a study published online on June 4, 2012, in Archives of Internal Medicine.

The study’s authors, based at Harvard Medical School, obtained data for all drug recalls in the United States between 2004 and 2011 from publicly accessible FDA Enforcement Reports. For Class I recalls, which the agency defines as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” they obtained information on the number of recalled lots and affected units, the geographic distribution of the recalled units, the reason for the recall, and the presence of adverse events associated with the recall.

The researchers found 1734 drug recalls in the enforcement reports, 91 (5%) of which were Class I recalls. Of these, 40% were due to contamination and 25% were due to incorrect dosage or release mechanism. 62% of the Class I recalls affected multiple lots; 70% affected more than 1000 units; and 80% involved units distributed nationwide or beyond. Five Class I recalls were initiated in response to adverse events ranging from lip swelling to death, although the authors note that this probably underestimates the number of recalls related to adverse events.

During the same period, the FDA issued 2912 Recall Alert System announcements, of which 55 were for Class I recalls, meaning that it did not issue such an announcement for 36 Class I recalls (40%). However, 18 of these recalls were communicated through the agency’s MedWatch system, including the 5 recalls initiated in response to adverse events. Still, this means that 18 (20%) of the Class I recalls were not communicated via either system.

The authors note that their findings indicate that health care providers may be incompletely informed about clinically important recalls, potentially jeopardizing patient safety. In addition, they note that those Class I recalls that are communicated through the Recall Alert System are mixed in with other recalls that are far less important, such as veterinary drug recalls, making it difficult for providers to focus on those recalls that are clinically relevant. The researchers note, however, that health care providers may have been alerted of some recalls via direct communication from drug manufacturers.

In addition to better communication of recalls, the authors argue that enhanced tracking of affected products through the supply chain to the patient is required to minimize the risk of exposure to potentially harmful products. For instance, use of radiofrequency identification technology could allow pharmacies to rapidly identify and notify affected patients as soon as a recall is initiated.